March 2023 FDA Recall Heparin Sodium In Dextrose by B. Braun Medical Inc
D-0434-2023 - Subpotent Drug
This Class II drug recall was initiated by B. Braun Medical Inc on March 1, 2023 for the product Heparin Sodium In Dextrose. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0434-2023
Subpotent Drug: low Anti-Factor IIa potency.
03-01-2023
03-15-2023
30672
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
B. Braun Medical Inc
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
03-13-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.Braun Medical Inc, Bethlehem, PA. 18018-3524 USA. NDC 0264-9587-20.
Batch or Lot Expiration Information
Lot# Lot J2C017; Expiration: 9/30/2023.
